Method and device for reducing angular bone deformity using a bone stabilization plate and cerclage material

ABSTRACT

The present invention is a method and device for the correction and reduction of bone deformities, such as metatarsus primus adductus, using a plate body with winged buttresses and dorsal loop. The method and device can be affixed to a bone without any drilling or violating of the bone and can use a tethering technique which does not require drilling into the second metatarsal, nor does it require the placement of a prominent suture knot/button device medially along the first metatarsal.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57.

This application is a divisional of U.S. application Ser. No. 13/720,826, filed on Dec. 19, 2012, which claims the benefit of U.S. Provisional Application Nos. 61/672,297, filed on Jul. 17, 2012 and 61/713,443, filed on Oct. 12, 2012.

STATEMENT REGARDING COPYRIGHTED MATERIAL

Portions of the disclosure of this patent document contain material that is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure as it appears in the Patent and Trademark Office file or records, but otherwise reserves all copyright rights whatsoever.

BACKGROUND OF THE INVENTION

This invention relates to surgical implant devices for repairing angular bone deformities, in particular, metatarsus primus adductus. While the invention was conceived for the purposes of correcting metatarsus primus adductus, it is conceivable that the invention can be adapted to correct other bone deformities as long as there is a stable bone somewhat adjacent to an unstable bone.

Metatarsus primus adductus is a progressive angular deformity in the foot, between the first and second metatarsals, when the unstable or hypermobile first metatarsal deviates medially, increasing the intermetatarsal angle between the first and second metatarsals. Surgical procedures to correct this condition are chosen based on the severity of the angular deformity. Traditionally, surgical correction of moderate to severe angular deformities between the first and second metatarsals involves bone remodeling, osteotomies, wedge resection of bone or joint fusions, which cause irreversible alterations to bone and joint structures. A more desirable technique is to anatomically correct the deformity by reducing the abnormally wide angle between the two metatarsals by tethering them closer together using suture like material. Known are U.S. Pat. Nos. 8,221,455, 7,901,431, 7,875,058, 5,529,075, and U.S. patent application Ser. No. 20/110,224,729.

U.S. Pat. Nos. 8,221,455, 7,901,431, 7,875,058 and U.S. patent application Ser. No. 20/110,224,729 are tethering techniques whereby fiberwire, a suture-like material, along with buttress plates and/or buttons are used to tether the first and second metatarsals closer together like a tightrope. These techniques require holes to be drilled through both the first and second metatarsals. The Mini Tightrope system by Arthrex is an example of the tethering technique. First, a hole is drilled through the first and second metatarsals. Next, a buttress plate is secured to the second metatarsal bone by passing the suture through holes in the plate and through holes in both bones, then reducing the angular deformity by tightening the suture using a button and suture knot located on the medial side of the first metatarsal. The Mini Tightrope FT system by Arthrex is another example of tethering technique which uses an anchor-suture-button complex, where a threaded anchor is drilled into the second metatarsal base and the suture thread is then passed through a hole in the first metatarsal and the angular deformity is reduced as the suture thread is tightened and secured with a suture knot and button located along the medial aspect of the first metatarsal. Both of these tethering techniques require drilling into both the second and first metatarsals. U.S. Pat. No. 5,529,075 is similar in that it too requires drilling through the first and second metatarsals. Instead of a flexible suture-anchor technique, this reference requires the installation of a rigid stabilizing member between the first and second metatarsal. However, each of these references suffers from one or more of the following disadvantages: a hole must be drilled into or through the second metatarsal, to secure one end of the tethering device while the other (medial) end of the tethering device is secured with a button.

Drilling a hole through the second metatarsal, which is significantly smaller in diameter by comparison to the first metatarsal, severely weakens the bone. To minimize weakening of the second metatarsal, the hole must be drilled through the centerline of the bone so that a maximum amount of bone remains above and below the hole. Nevertheless, drilling a hole through the centerline of the second metatarsal is especially difficult because it is done at an angle through a hole in the first metatarsal. Making the procedure more difficult, the drilling must be done with little or no visibility. A second metatarsal bone which has been drilled through is more vulnerable to stress and/or fracture from tension caused by the tethering techniques. Fracture of the second metatarsal is a common and potentially devastating complication of these tethering techniques. Additionally, the use of buttons and suture knots located along the medial aspect of the first metatarsal can cause irritation of tissue, knot loosening and skin irritation/breakdown from prominent components.

Some surgeons have attempted to avoid drilling into the second metatarsal via a modification of the tethering technique, known as lasso technique. With the lasso technique, no holes are drilled through the second metatarsal, and no buttress plate or button is used. Instead, suture tape (i.e. Fibertape) is tied around the second metatarsal in the form of a cow-hitch knot and then secured to the first metatarsal. While the lasso technique avoids drilling through the second metatarsal by instead looping suture tape around the metatarsal, the suture tie itself can cause periosteal reaction and bone callus formation in some patients due to friction between the suture tape and the bone. To avoid periosteal reaction, few surgeons use absorbable suture to tether the first and second metatarsals together, but once the suture finally absorbs there is likely some loss of correction and possible recurrence of angular deformity.

Because of the aforementioned problems, there is a need for method and device for reducing angular bone deformities between two bones, using a tethering technique with a suture material which not only avoids the complications associated with drilling into the second metatarsal, but also avoids the friction and tension forces (i.e. rope-burn) associated with lasso-type techniques and which also avoids the complications associated with the prominent medial button and suture knot.

The present invention satisfies this need in the form of a method and device that allows for the correction and reduction of angular deformities such as metatarsus primus adductus using a tethering technique which does not require drilling into the second metatarsal, nor does it require the placement of a prominent suture knot/button device medially along the first metatarsal.

SUMMARY

The inventive device is a Winged Looped Plate comprising a plate body with winged buttresses and dorsal loop. The Winged Looped Plate with incorporated dorsal loop can be affixed to a bone without any drilling or violating of the bone. With the plate against the bone cortex, a circlage technique can be used to loop circlage material, such as suture tape, fibertape, or wire, around the plate and bone. The circlage material is passed through the dorsal loop of the plate to keep the circlage material centered on the plate. The circlage material is tied around the second metatarsal using a lasso-type or cowhitch-type tie, Then, upon tightening the circlage, the plate would be affixed to the bone under tension, thereby dispensing with the need to affix the plate to the bone with screws or drilled holes. The other end of the tethering mechanism can then be fixated to the first metatarsal (with the angular deformity anatomically reduced) using knotless anchors (interference screws) thus avoiding the use of prominent buttons and suture knots that are components of all other comparative tethering methods. By using a circlage technique to affix the Winged Looped Plate to bone under tension, the second metatarsal is protected not only from drill hole related stress fractures, but also from friction/shear forces (cortical reaction) associated with tying suture around bone and directly against the bone cortex without any shielding.

This method and device addresses the aforementioned existing problem of angular bone deformities, in particular metatarsus primus adductus, the underlying cause of hallux valgus/bunion deformities, by utilizing the Winged Looped Plate of the present invention, placed directly against the second metatarsal bone.

The Winged Looped Plate allows the surgeon to tie circlage material around the plate, protecting the bone from both friction and tension forces and eliminating need for drilling through the second metatarsal. The method uses the Winged Looped Plate, circlage material, a suture passing instrument and two tenodesis (interference) screws to achieve a true reduction of the angular deformity. The two bones are tethered together using a circlage technique with the Winged Looped Plate protecting the second metatarsal, while knotless anchors are used in the first metatarsal. This method creates a button-less, knotless, fully adjustable and reversible angular deformity correction, while the plate protects the second metatarsal bone from harmful tension and friction.

While the invention was conceived for the purposes of correcting metatarsus primus adductus, it is conceivable that the invention can be adapted to correct other bone deformities as long as there is a stable bone somewhat adjacent to an unstable bone.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a device embodying features of the present invention for a method and device for correcting bone deformities such as metatarsus primus adductus.

FIG. 2 is a side profile view of a device embodying features of the present invention for a method and device for correcting bone deformities such as metatarsus primus adductus.

FIG. 3 is a front profile view of a device embodying features of the present invention for a method and device for correcting bone deformities such as metatarsus primus adductus.

FIG. 4 is a top view of a skeleton embodying features of the present invention for a method and device for correcting bone deformities such as metatarsus primus adductus.

FIG. 5 is a profile view from the second metatarsal of a skeleton embodying features of the present invention for a method and device for correcting bone deformities such as metatarsus primus adductus.

FIG. 6 is a profile view from the first metatarsal of a skeleton embodying features of the present invention for a method and device for correcting bone deformities such as metatarsus primus adductus.

FIG. 7 is a profile view of a medial incision made along the first metatarsal with tenodesis (interference) screws anchoring the suture tape to the first metatarsal.

FIG. 8 is an illustration of the bone deformity, metatarsus primus adductus, before the device and method of the present invention is applied.

FIG. 9 is an illustration of the bone deformity, metatarsus primus adductus, anatomically reduced after the device and method of the present invention is applied.

FIG. 10 is an alternate embodiment of the Winged Looped Plate device embodying features of the present invention for protection of a long bone when using any circlage technique in a series as may be necessary for longer bones. An elongated version of the Winged Looped Plate allows for multiple wings and multiple loops for applying a series of circlage ties over a longer bone. This figure also shows a possible low-profile variation of the loops if the circlage material is thinner (i.e. monofilament wire).

FIG. 11 is a flowchart illustrating a method of using the present invention for the correction of a bone deformity.

DETAILED DESCRIPTION

FIGS. 1-3 illustrate the current embodiment of the Winged Looped Plate 100 device to correct bone deformities, in particular metatarsus primus adductus, the underlying cause of hallux valgus/bunion deformities. The Winged Looped Plate 100 comprises a plate body 102 which is semi-tubular but can also be tubular, with buttress wings 104, a dorsal loop 106, and ingrowth holes 108. Depending on where the plate is to be used, the number of buttress wings 104, the number and shape of the dorsal loops 106, and size and number of holes 108 on the plate body can be customized. For example, several sets of buttress wings 104, dorsal loops 106, and ingrowth holes 108 can be arranged in series along a plate body for use in longer bones when a series of circlage ties are needed. (FIG. 10). The plate body 102 is semi-tubular in shape with a convex outer surface and concave inner surface to distribute forces of the suture tape evenly and avoid the need to drill a hole through the bone. The plate body 102 comprises extension buttress wings 104 which follow the semi-tubular shape of the plate body to protect the adjacent bone cortices where suture tape wraps around the device and bone. The plate body 102 and buttress wings 104 may have ingrowth holes 108 to allow bony and soft tissue/scar tissue ingrowth for long-term fixation and stability of the plate position. The dorsal loop 106 extends from the outer convex surface of the plate body 102 to facilitate the threading of circlage material, such as suture tape, fibertape, or wire, around the device. The dorsal loop 106 retains the circlage material centered on the plate upon tightening to evenly secure the plate firmly against the bone under tension.

The invention can be fabricated to comprise the plate body 102, buttress wings 104, dorsal loop 106, and holes 108 using conventional manufacturing methods such as welding, pressing, casting, machining and/or forging. A variety of materials may be used including, metallics (i.e. titanium, stainless steel), bio absorbables (i.e. Poly-L-Lactide PLLA) or non-absorbables (i.e. PEEK polymer). Additionally, the inner surface of the Winged Looped Plate 100 could be plasma coated or otherwise roughened for enhanced grip to bone.

FIG. 11 is a flowchart illustrating the correction of a bone deformity using the method and device of the present invention. First, an unstable bone 301 and a stable bone 302 near the unstable bone 301 is located (FIG. 4). Second, a hole to accommodate a tenodesis (interference type) screw 204 is drilled through the unstable bone 301 (FIG. 5) so that an opening is formed on the side of the unstable bone that is furthest away from the stable bone (FIG. 9). Third, a Winged Looped Plate 100 is placed with the inner surface against the stable bone 302 and with the dorsal loop 106 furthest away from the unstable bone 301 (FIG. 5). Fourth, a circlage material 202 is passed through the dorsal loop 106 of the Winged Looped Plate 100 on the stable bone 302 and tied around the stable bone 302 and Winged Looped Plate 100 using a circlage technique (FIG. 5). Fifth, the free ends of the circlage material 202 are passed through the hole in the unstable bone 301 and tension is applied to the suture 202 to reduce the angular bone deformity (FIG. 6). Sixth, the circlage material 202 is secured to the unstable bone 301 using a tenodesis (interference-type) screw 204 in the drill hole (FIG. 6).

FIGS. 4-9 illustrate a method of using a Winged Looped Plate 100 to correct the angular bone deformity, metatarsus primus adductus. First, a medial incision is made along the first metatarsal 301 (the unstable bone) head and neck as best illustrated in FIG. 7. Second, a small incision is made dorsally over the second metatarsal 302 (the stable bone) neck. Third, blunt dissection is used to create a tunnel through the soft tissue between the first metatarsal 301 and second metatarsal 302, connecting the two incisions. Third, circlage material 202 is passed through the tunnel from medial to lateral, and located through the dorsal incision where it is then threaded through the dorsal loop 106 of the Winged Looped Plate 100, which is then placed against the lateral cortex of the second metatarsal before the circlage material 202 is tied once around the second metatarsal 302 using a circlage technique, as best illustrated in FIGS. 4-5.

Fourth, the cerclage material 202 is tightened so that the Winged Looped Plate 100 is pressed firmly against the lateral aspect of the second metatarsal 302 and that buttress wings 104 of the plate cover and protect the dorsal and plantar cortices of the second metatarsal 302. The plate would be adhered to the bone primarily via tension from tightening the suture tape circlage however, additional forms of optional fixation may include a single setscrew through a hole 108 in the dorsal wing 104, bone glue/paste/putty or other fixatives. Fifth, the free ends of the circlage material 202 are then passed back through the soft tissue tunnel medially, then through a drill hole in the first metatarsal 301, from lateral to medial as illustrated in FIGS. 6-7. Sixth, the circlage material 202 is pulled tightly through the drill hole, reducing the angular deformity to a more anatomic position, as illustrated in FIGS. 8-9. Seventh, a tenodesis anchor screw 204, shown in FIGS. 6-7, is inserted into the drill hole as an interference screw to maintain tension across the tethering mechanism between the first and second metatarsals. Finally, a second point of fixation can be achieved by passing the remaining circlage material 202 end through a second drill hole in the first metatarsal and inserting a second tenodesis screw 204.

All features disclosed in this specification, including any accompanying claim, abstract, and drawings, may be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features.

Any element in a claim that does not explicitly state “means for” performing a specified function, or “step for” performing a specific function, is not to be interpreted as a “means” or “step” clause as specified in 35 U.S.C. §112, paragraph 6. In particular, the use of “step of” in the claims herein is not intended to invoke the provisions of 35 U.S.C. §112, paragraph 6.

Although preferred embodiments of the present invention have been shown and described, various modifications and substitutions may be made thereto without departing from the spirit and scope of the invention. Accordingly, it is to be understood that the present invention has been described by way of illustration and not limitation. 

The invention claimed is:
 1. A method of bone stabilization between an unstable bone and a stable bone, comprising: making a first incision adjacent a second, stable metatarsal of a foot; passing cerclage material into the first incision, around the second metatarsal, and back out through the first incision; threading the cerclage material through a dorsal loop of a bone stabilization plate; disposing the bone stabilization plate against a lateral cortex of the second metatarsal; tying the cerclage material around the second metatarsal and the bone stabilization plate in a cerclage fashion; making a second incision along a first, unstable metatarsal of the foot; drilling a hole through the first metatarsal; creating a tunnel through soft tissue between the first metatarsal and the second metatarsal, the tunnel connecting the first and second incisions; passing free ends of the cerclage material through the tunnel from lateral to medial direction and pulling the free ends of the cerclage material through the hole in the first metatarsal; applying tension to the cerclage material while reducing angular deformity between the first and second metatarsals; inserting an interference screw medially in the hole of the first metatarsal, thereby fixing the cerclage material to the first metatarsal under tension; and pulling the free ends of the cerclage material through a second drill hole in the first metatarsal and inserting a second interference screw medially into the second hole.
 2. The method of claim 1, further comprising inserting a set screw through a hole in the bone stabilization plate, and through a dorsal cortex of the metatarsal.
 3. The method of claim 1, wherein tying the cerclage material around the second metatarsal and the bone stabilization plate comprises using a lasso-type or cowhitch-type tie.
 4. The method of claim 1, wherein the bone stabilization plate comprises: a plate body with a convex outer surface and a concave inner surface; and at least one buttress wing extending perpendicularly from a longitudinal axis of the plate body, wherein the dorsal loop is disposed on the convex outer surface of the plate body.
 5. The method of claim 4, wherein the buttress wing is aligned with the dorsal loop along an axis orthogonal to the longitudinal axis of the plate body.
 6. The method of claim 4, wherein after applying tension to the cerclage material, the cerclage material extends over the at least one buttress wing. 